Your clinic has a doctor on staff. Every patient has a consultation. Prescriptions go to a compounding pharmacy, and the product arrives labelled with the patient's name. On paper, everything looks lawful.

But a consultation, a prescription and a label do not answer every regulatory question. The Therapeutic Goods Administration (TGA) and professional regulators can also examine how the product reached the patient, how the clinic found that patient, and whether the treatment was clinically appropriate.

In our previous article on the TGA's unapproved-peptide crackdown, we explained the enforcement focus and the law behind it. This follow-up turns that framework into practical questions for clinic owners, prescribers and pharmacy partners.

It covers four areas clinics most need to get right: lawful access, advertising, supply-chain and clinical records, and governance. It finishes with common mistakes and a checklist for reviewing your own practice.

Peptides are not prohibited as a category. Some peptide-based medicines are approved. The analysis must identify the particular product, its ARTG status, scheduling and intended use, rather than treating every medicine described as a peptide alike.

01 How do you get the product to the patient lawfully?

Many peptide products promoted for recovery, anti-ageing or performance are not included in the Australian Register of Therapeutic Goods (ARTG). Unless an applicable exemption, approval or authority applies, an unapproved therapeutic good cannot simply be supplied because a doctor has written a prescription.

The first task is to identify what permits each relevant activity: importation, manufacture or compounding, prescribing, dispensing and supply. A pathway that permits patient access does not necessarily resolve manufacturing, customs or state and territory medicines requirements. It never creates a general permission to advertise prescription-only or unapproved medicines to the public.

The Special Access Scheme

The Special Access Scheme (SAS) provides access to unapproved therapeutic goods for individual patients. Category B requires a clinical application and TGA approval before supply. Categories A and C are notification pathways, but only where the patient, product and practitioner meet their respective eligibility requirements. Required notifications must be submitted within 28 days. Category C is confined to goods, indications and practitioner types on the relevant list.

Do not assume that a particular peptide qualifies for a notification pathway. Check the product, patient circumstances and current TGA requirements. Category A is confined to seriously ill patients meeting the statutory definition and is available to medical practitioners. A Category B application should explain the therapeutic need, why approved alternatives are unsuitable, and the evidence supporting the proposed treatment. The strength and relevance of the human evidence matter; laboratory findings or overseas promotional claims do not establish that a proposed treatment is appropriate for that patient.

The Authorised Prescriber Scheme

The Authorised Prescriber Scheme allows a medical practitioner authorised by the TGA to prescribe specified unapproved goods for the authorised indication and patient class. It is not an authority held by the clinic, and it is not a general licence to prescribe any peptide to any patient.

The standard pathway generally requires approval from a human research ethics committee or endorsement from a relevant specialist college. A separate established-history-of-use pathway is available for eligible medicines and indications on the TGA's list without that supporting approval or endorsement. Clinics must check the actual authority, its conditions and reporting obligations rather than assuming either pathway is available for their preferred product. Authorised Prescribers must submit six-monthly patient-number reports, due on 31 July and 31 January, and comply with their authority's conditions.

Pharmacy compounding

A pharmacist may prepare certain medicines for an individual patient under a conditional exemption from ARTG inclusion. Schedule 5 item 6 of the Therapeutic Goods Regulations 1990 provides an exemption for medicines dispensed or extemporaneously compounded for a particular person for therapeutic application to that person, subject to express exclusions. These include gene therapies, medicinal cannabis products and medicines containing GLP-1 receptor agonist analogues. A patient name on a label is not proof that those conditions have been met. The arrangements must satisfy the relevant exemption and any separate manufacturing-licence requirements, as well as state or territory law and professional standards.

Compounding is not a general authorisation to manufacture and distribute unapproved medicines at scale. The timing of preparation, the patient-specific therapeutic need, the prescription, premises and manufacturing arrangements all matter. Sterile injectable preparations require particular scrutiny of facilities, processes, ingredient quality and contamination risks.

The Pharmacy Board's compounding guidance requires an evidence-based assessment of safety, quality and efficacy. Uncertainty about a novel peptide cannot be resolved simply by finding a pharmacy willing to prepare it. Prescribers and pharmacists need to assess their respective responsibilities and the supporting evidence.

Product-specific exclusions must also be checked. From 1 October 2024, medicines containing GLP-1 receptor agonist analogues compounded on or after that date were excluded from the relevant pharmacist compounding exemption, regardless of dosage form. That change is not a blanket ban on all peptide compounding, but it means the usual exemption cannot be assumed to cover those products.

A prescription is one part of the clinical process. It is not a substitute for a lawful access pathway, a lawful supply chain or an advertising review.

02 How can you promote your clinic without breaking the advertising rules?

Advertising is an immediately visible source of regulatory risk. A clinic's website, social-media accounts and booking journey can provide public evidence of the products it promotes and the way patients are encouraged to seek them.

The Commonwealth framework generally prohibits advertising prescription-only medicines to the public and restricts advertising unapproved therapeutic goods. The assessment is not limited to whether a brand or chemical name appears. Indirect references, images, medicine classes and the overall impression of the content may also promote the use or supply of therapeutic goods.

You can advertise a health service, including consultations and accurate information about practitioners' qualifications and conditions assessed, provided the advertising itself complies with the applicable rules. What you cannot safely do is present the service as a route to obtaining prescription-only or unapproved products. On 18 June 2026, the TGA published prescription-medicine advertising guidance and updated its health-service guidance. This explains existing restrictions rather than creating a new ban. The health-service guidance considers the whole context, including business names, logos, booking systems, intake forms, price lists and linked material.

Review the whole patient journey

Content that warrants close review includes:

  • Peptide names, abbreviations, nicknames or recognisable product images.
  • Descriptions such as “peptide therapy”, where the context promotes prescription-only or unapproved products.
  • Peptide menus, packages, subscription offers and medicine price lists.
  • Claims about faster healing, fat loss, performance or anti-ageing.
  • Before-and-after photographs or testimonials implying that a medicine produced a result.
  • Influencer posts, affiliate codes and links to third-party product promotions.
  • Eligibility quizzes and booking flows that steer prospective patients towards a particular medicine.
  • Emails or texts to past patients that promote products, rather than providing appropriate information in the course of their treatment.

These are review triggers, not a statement that every image or every educational mention of a peptide is unlawful. Purpose, audience, content and context matter. Putting promotional content behind a consumer login or membership wall does not necessarily take it outside the advertising rules.

The separate health-service advertising rules

Anyone advertising a regulated health service, including a business owned by non-practitioners, must also comply with section 133 of the Health Practitioner Regulation National Law as it applies in the relevant jurisdiction.

It prohibits false, misleading or deceptive advertising; offers of gifts, discounts or other inducements without stating the terms and conditions; testimonials or purported testimonials about the service; advertising that creates an unreasonable expectation of beneficial treatment; and advertising that directly or indirectly encourages indiscriminate or unnecessary use of regulated health services. Ahpra's guidance explains that its testimonial restriction concerns clinical aspects of care, rather than every comment about matters such as reception service or parking.

Stating an offer's terms and conditions does not cure a breach of another advertising restriction. An advertisement may engage both regulatory frameworks. Multiple posts, channels and periods of publication can increase exposure, but the legal characterisation of contraventions and any penalty depends on the applicable provision and facts. There is no safe assumption that a whole campaign counts as only one breach, or that every post automatically attracts the statutory maximum.

04 Governance: who is responsible?

In some business models, the doctor assumes the pharmacy has compliance covered, the pharmacy assumes the doctor does, and the owner assumes both do. Each participant still needs to identify its own obligations.

Directors and owners can face personal exposure

A company structure is not complete protection. Depending on the statutory provision and evidence, individuals who participate in a contravention may face accessorial or other personal liability. Holding office as a director, or owning the business, does not by itself establish that liability.

In its 28 September 2026 announcement concerning BioV8, the TGA reported proceedings against the company in liquidation and two former directors, alleging that the directors aided, abetted, counselled or procured unlawful advertising. Those are allegations, not findings. The announcement stated that commencement against the company was subject to Federal Court leave; this article does not confirm a subsequent leave decision or the current court status.

A non-practitioner owner is not exempt from the business's advertising obligations simply because they do not prescribe. Equally, different participants may have different interests when an investigation begins, and separate advice may be appropriate.

Practitioners face professional regulation as well

A TGA investigation and a professional-regulation process are distinct. Unsafe prescribing, inadequate assessment, deficient consent or poor records may raise registration concerns even where a business considers its supply pathway lawful. Regulatory action can include conditions or other restrictions, suspension, and, through the applicable process, cancellation of registration. The outcome depends on the statutory powers, evidence and procedural stage.

Telehealth is not a shortcut

The Medical Board's telehealth guidelines state that prescribing for a patient without a real-time consultation, in person, by video or telephone, is not good practice, subject to the circumstances identified in the guidelines, effective from 1 September 2023. These recognise that prescribing without a consultation may be appropriate for the patient's usual practitioner or another practitioner with access to the patient's clinical record. A practitioner departing from the standard must be able to explain why the prescribing and management were appropriate and necessary. Those circumstances should not be treated as a general justification for an online questionnaire that leads directly to a peptide prescription.

A telehealth consultation must still allow an adequate clinical assessment. The practitioner needs to decide whether remote care is appropriate, whether an examination or in-person review is required, and whether they have enough information to prescribe safely. Records, consent, follow-up and continuity of care remain important.

Review commercial incentives

Revenue sharing, commissions, exclusive referrals and arrangements between a clinic, prescribers and a pharmacy can create conflicts of interest. They are not all automatically unlawful, but they warrant review against professional obligations, disclosure requirements and the actual supply model. Financial incentives must not displace independent clinical judgment.

A written agreement does not cure an unlawful arrangement. Check what happens in practice: who selects the medicine, who receives payment, who controls patient communications and who is responsible for complaints, recalls and adverse-event escalation.

Someone needs to own compliance

Recommended governance measures include a nominated compliance lead, written responsibilities, staff training, periodic review and a plan for regulatory contact. It does not transfer every participant's legal responsibility to that person.

05 Common mistakes

“We took the posts down, so the problem's gone.”

Removing non-compliant advertising can address an ongoing risk, but it does not erase past conduct. Preserve published versions and relevant records before making necessary changes. Screenshots and archived content may remain available to a regulator. Get advice on whether further action or a response is needed.

“Other clinics are doing the same thing.”

Another clinic's conduct is not a defence. The TGA's risk-based priorities help explain where it directs resources, but visibility is not the same as legality. A smaller business should not assume that limited advertising protects it from investigation.

“It's sold overseas, so it must be safe.”

Overseas availability, overseas compounding arrangements or a supplier's certificate do not establish Australian regulatory approval or clinical suitability. Verify the particular Australian product and pathway. Do not confuse a product being commercially available with a regulator having assessed its safety, quality and effectiveness.

“We'll deal with it if we get a letter.”

By the time a regulator contacts the clinic, it may already hold substantial evidence. Identify the power being used, the recipient and the deadline. Preserve records, obtain advice early and check what must be produced before responding. A request, compulsory notice, infringement notice and court document are not interchangeable.

“Our marketing agency handles compliance.”

Outsourcing marketing does not remove the clinic's own responsibilities. Agencies, influencers and other participants may also have exposure depending on their conduct. Review material published in the clinic's name, including linked content and changes made after the initial approval.

06 A compliance checklist for your clinic

Use these questions to review your practice. A “yes” should be supported by records, not assumptions. The checklist is a starting point, not a certification that a business model is lawful.

  1. Products. Do we maintain a current product list showing ARTG status, scheduling and intended use?
  2. Pathways. Is there a documented lawful basis for each relevant activity, with patient-specific approvals, authorities, exemptions and notifications where required?
  3. Pharmacy. Have we checked the actual compounding arrangements, the exemption's conditions, product exclusions and sterile-preparation requirements?
  4. Supply chain. Can we trace products and ingredients to a lawful source and relevant batch and import records?
  5. Records. Do clinical notes demonstrate therapeutic need, adequate assessment, supporting evidence and consideration of approved alternatives?
  6. Consent. Do patients receive and understand information about unapproved status, evidence limitations, risks, alternatives and follow-up, with consent documented?
  7. Advertising. Has someone familiar with both TGA and health-service advertising rules reviewed our website, booking flow, social media, emails and influencer content?
  8. Arrangements. Are supplier, pharmacy, prescriber and marketing agreements documented and assessed for conflicts and problematic incentives?
  9. Governance. Is responsibility allocated, with training and a plan for regulatory notices, complaints and document preservation?
  10. Monitoring. Do we have systems for adverse events and the applicable 15-day reporting duty, product defects, recalls, 28-day SAS notifications, six-monthly Authorised Prescriber reporting, authority conditions and changes to regulatory guidance?

For NSW clinics, there is also an imminent medicines-law transition. NSW Health states that the Medicines, Poisons and Therapeutic Goods Act 2022 and Regulation 2026 replace the existing Poisons and Therapeutic Goods Act 1966 and Regulation 2008 from 5 November 2026. Review the requirements relevant to the clinic, and assess historical conduct under the law applicable at the time.

07 How GopherWood Lawyers can help

The peptide market is moving quickly, and so are the regulators. A clinic's legal position depends on its actual products, pathways, advertising and arrangements, not simply the presence of a doctor or a compounding pharmacy.

We can help you:

  • Review regulatory exposure across products, access pathways, records and consent processes.
  • Review pharmacy, supplier, prescriber and marketing arrangements.
  • Assess website and social-media material against the relevant advertising rules.
  • Prepare or review compliance policies, consent documentation and staff-training material, with appropriate clinical input.
  • Review the legal implications of changes in regulatory requirements.
  • Respond to TGA correspondence, compulsory notices, infringement notices and professional-regulation notifications.

If your clinic prescribes, compounds, supplies or promotes peptide products, contact GopherWood Lawyers for a confidential discussion, call 02 9160 2157 or email info@gopherwoodlawyers.com.au.

This article reflects regulatory material reviewed on 23 October 2026. It is general information, not legal or medical advice. Clinical decisions require appropriate professional judgment, and the legal position depends on the product, conduct and jurisdiction.

08 Sources and further reading

The BioV8 discussion reports the TGA's announcement, not a subsequent court outcome. Check current guidance, product lists and approval conditions before acting.

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